Diprosalik ointment, 30 g

Reduction of inflammatory manifestations of dry and hyperkeratic dermatoses sensitive to GCS therapy, including psoriasis, chronic atopic dermatitis, neurodermatitis (chronic lichen simplex), lichen planus, eczema (including coin-like eczema, eczema of the hands, eczematous dermatitis), dyshidrosis , seborrheic dermatitis of the scalp, ichthyosis and other ichthyosis-like conditions.

Outwardly. Apply in a thin layer 2 times a day - in the morning and at night, completely covering the affected skin. In some patients, a supportive effect can be achieved with less frequent applications. Children aged 2 to 12 years old - apply a thin layer on a small area of ??the skin 1 or 2 times a day for no more than 1 week.

1 g contains
active ingredients: betamethasone dipropionate 0.64 mg (equivalent to 0.5 mg betamethasone) and salicylic acid 30 mg;
excipients: liquid paraffin, petroleum jelly.

- Hypersensitivity to any of the components of the drug.
- Children under 2 years old.
- Pregnancy (long-term treatment in high doses).
- Lactation period.
- Rosacea, perioral dermatitis.
- Bacterial, viral or fungal skin infection (pyoderma, syphilis, skin tuberculosis, Herpes simplex, chickenpox, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis).
- Trophic ulcers against the background of chronic venous insufficiency.
- Skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma).
- Post-vaccination skin reactions.

With caution
Children under 12 years of age, liver failure, long-term treatment, use on large areas of the skin, the use of occlusive dressings.

The trade name of the drug is DIPROSALIKЃ.

The dosage form is an ointment for external use.

Composition
1 g contains
active ingredients: betamethasone dipropionate 0.64 mg (equivalent to 0.5 mg betamethasone) and salicylic acid 30 mg;
auxiliary substances: liquid paraffin, petroleum jelly.

Description
Homogeneous ointment of soft consistency, almost white, without visible particles.

Pharmacotherapeutic group
Glucocorticosteroid + keratolytic agent.

Pharmacological properties
A combined preparation based on two active ingredients - betamethasone dipropionate and salicylic acid. Betamethasone dipropionate - a synthetic fluorinated glucocorticosteroid (GCS) - has anti-inflammatory, antipruritic and vasoconstrictor effects.
When applied topically, salicylic acid has keratolytic, as well as bacteriostatic and some fungicidal effects.

Indications for use
Reduction of inflammatory manifestations of dry and hyperkeratic dermatoses sensitive to GCS therapy, including psoriasis, chronic atopic dermatitis, neurodermatitis (chronic lichen simplex), lichen planus, eczema (including coin-like eczema, eczema of the hands, eczematous dermatitis ), dyshidrosis, seborrheic dermatitis of the scalp, ichthyosis and other ichthyosis-like conditions.

Contraindications
- Hypersensitivity to any of the components of the drug.
- Children under 2 years old.
- Pregnancy (long-term treatment in high doses).
- Lactation period.
- Rosacea, perioral dermatitis.
- Bacterial, viral or fungal skin infection (pyoderma, syphilis, skin tuberculosis, Herpes simplex, chickenpox, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis).
- Trophic ulcers against the background of chronic venous insufficiency.
- Skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma).
- Post-vaccination skin reactions.

With caution
Children under 12 years of age, liver failure, long-term treatment, use on large areas of the skin, the use of occlusive dressings.

Use during pregnancy and lactation
Due to the fact that the safety of using local GCS in pregnant women has not been established, the appointment of this class of drugs during pregnancy is justified only if the potential benefit to the mother outweighs the potential risk to the fetus.
Drugs in this class should not be used during pregnancy in high doses or for a long time.
Since it has not yet been clarified whether the level of systemic absorption of local GCS is sufficient for the appearance of their detectable concentrations in the mother's milk, either breastfeeding or the use of the drug should be stopped, taking into account how much its use is necessary for the mother.

Method of administration and dosage
Outwardly. Apply in a thin layer 2 times a day - in the morning and at night, completely covering the affected skin. In some patients, a supportive effect can be achieved with less frequent applications. Children aged 2 to 12 years old - apply a thin layer on a small area of ??the skin 1 or 2 times a day for no more than 1 week.

Side effects
Adverse events that occurred when using local GCS included burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis, purpura, telangiectasia, local hirsutism, ... The following phenomena more often occurred with the use of occlusive dressings: skin maceration, secondary infection, skin atrophy, striae and prickly heat.
If you experience adverse reactions that are not described in this instruction, you should consult a doctor.

Overdose
Symptoms. Long-term use of local corticosteroids in high doses can cause inhibition of the function of the pituitary-adrenal system, leading to secondary insufficiency of the adrenal glands and hypercortisolism, including Cushing's syndrome. Prolonged use in high doses of preparations containing salicylic acid can lead to salicylic acid poisoning.
Treatment.Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance. In case of chronic toxicity, gradual withdrawal of GCS is recommended. In case of an overdose of salicylates, treatment is also symptomatic. Measures should be taken to eliminate salicylates from the body as soon as possible, for example, ingestion of sodium bicarbonate (to alkalinize urine) and forcing diuresis.

Interaction with other medicinal products
Any interaction of the drug Diprosalik ointment with other medicinal products has not been registered.

Special instructions
If irritation or hypersensitization develops against the background of the use of the drug, treatment should be discontinued. In case of infection, appropriate therapy should be prescribed. With local application of GCS, especially in children, there may be side effects characteristic of systemic GCS, including inhibition of the function of the hypothalamic-pituitary-adrenal system.
Systemic absorption of corticosteroids and salicylic acid when applied topically will be higher when using occlusive dressings, as well as if extensive body surfaces are treated.
With long-term drug treatment, it is recommended to withdraw it gradually.
The drug is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.

Application in pediatrics
Application in children under 12 years of age is possible only under medical supervision. Children more than adults are at risk of suppression of the function of the hypothalamic-pituitary-adrenal system when using local GCS due to the greater value of the ratio of body surface area to its mass and, as a result, increased absorption of the drug.
There were reports of a decrease in the function of the hypothalamic-pituitary-adrenal system, Cushing's syndrome, growth retardation, insufficient weight gain and increased intracranial pressure in children who received GCS for topical use. The suppression of the function of the hypothalamic-pituitary-adrenal system in children is determined by a low level of cortisol in plasma and a lack of response to stimulation of adrenocorticotropic hormone. Increased intracranial pressure is manifested by protrusion of the fontanelle, headaches, bilateral edema of the optic nerve head.

Release form
Ointment for external use. 30 g each in aluminum tubes, treated with epoxy varnish and closed with a membrane and a screw-on polyethylene cap with a perforator for opening the membrane. One tube together with instructions for use in a cardboard box.

Storage
conditions Keep out of the reach of children, at a temperature not exceeding 25 oC.

Shelf life is
5 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies
Without prescription.